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Vessel Wall Response of the Bio-Active-stent and Everolimus-Eluting Stent Assessed By Optical Coherence Tomography (BASE-OCT)

This study has been completed.
Sponsor:
Information provided by:
The Hospital District of Satakunta
ClinicalTrials.gov Identifier:
NCT01080859
First received: March 3, 2010
Last updated: May 4, 2011
Last verified: May 2011
History of Changes
  Purpose

The purpose of the trial is to evaluate the completeness of struts coverage and vessel wall response (strut malapposition, neoin-timal formation) to the bio-active-stent (BAS) versus ever-olimus-eluting stent (EES) implanted for the treatment of the culprit lesion in acute coronary syndrome.


Condition Intervention Phase
Acute Coronary Syndrome
 Device: OCT
 Phase 3

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Early Coverage and Vessel Wall Response of the Bio-Active-stent and Everolimus-Eluting Stent Implanted in Acute Coronary Syndrome Assessed By Optical Coherence Tomography (BASE-OCT)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The Hospital District of Satakunta:

Primary Outcome Measures:
  • Uncovered stent struts [ Time Frame: 6-8 months ] [ Designated as safety issue: Yes ]
    OCT number of uncovered stent struts for BAS versus EES.


Secondary Outcome Measures:
  • Cardiac death,MI, stent thrombosis (ST) and TLR. [ Time Frame: 1, 6, 12 and 18 months ] [ Designated as safety issue: Yes ]
    Device oriented composite endpoint, defined as cardiac death,MI, stent thrombosis (ST) and TLR at at 1, 6, 12 and 18 months.


Estimated Enrollment: 40
Study Start Date: December 2009
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
BAS
Patient's receiving BAS
 Device: OCT
Optical coherence tomography
Other Name: TITAN-2, Hexacath, France
EES
Patients receiving EES
 Device: OCT
Optical coherence tomography
Other Name: Xience-V, Abbott vascular, USA

Detailed Description:

A prospective, randomized and controlled study comparing the coverage of the BAS and EES implanted in acute coronary syndrome.

Clinical follow-up at 1, 6, 12 and 18 months. OCT analysis at the time of the 6 to 8 months follow-up.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients presenting with acute coronary syndrome and who were treated either BAS or EES during the index PCI.

Criteria

Inclusion Criteria:

  • Patient is ≥ 18 years old;
  • The patient is presenting with acute coronary syndrome, and according to hospital routine practice, eligible for percutaneous coronary intervention;
  • Patient or the patient's legal representative has been informed of the nature of the study and has provided written informed consent as approved by the Institutional Ethics Committee of the respective clinical site.

Exclusion Criteria:

  • Lesions in coronary artery bypass grafts
  • Left main disease
  • Killip class III-IV
  • Allergy to aspirin / thienopyridine
  • Patient in anticoagulation therapy
  • No suitable anatomy for OCT scan
  • Ostial lesion
  • Tortuosity anatomy
  • Very distal lesion
  • Vessel size > 3.75 mm
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01080859

Locations
Finland
Satakunta Central Hospital
Pori, Finland, 28500
Sponsors and Collaborators
The Hospital District of Satakunta
Investigators
Principal Investigator: Pasi P Karjalainen, MD, PhD Satakunta Central Hospital, Pori Finland
Study Chair: Antti Ylitalo, MD, PhD Satakunta Central Hospital, Pori, Finland
  More Information

No publications provided

Responsible Party: Satakun Hospital District, Satakunta Central Hospital
ClinicalTrials.gov Identifier: NCT01080859     History of Changes
Other Study ID Numbers: SA-004
Study First Received: March 3, 2010
Last Updated: May 4, 2011
Health Authority: Finland: Ethics Committee

Keywords provided by The Hospital District of Satakunta:
titanium
everolimus
oct
acute coronary syndrome
 stent
pci
stenting

Additional relevant MeSH terms:
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Everolimus
Sirolimus
 Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Antifungal Agents
Anti-Infective Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on May 16, 2013